[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)]
[Notices]
[Page 35667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16066]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive Patent License: Radiotherapy for 
Metastatic Castration-Resistant Prostate Cancer

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The National Heart, Lung and Blood Institute (NHLBI), National 
Institutes of Health, Department of Health and Human Services, is 
contemplating the grant of an exclusive commercialization patent 
license to Sinotau Pharmaceutical Group, headquartered in Beijing, 
China, to practice the inventions embodied in the patent application(s) 
listed in the Supplementary Information section of this notice.

DATES: Only written comments and/or applications for a license which 
are received by the NHLBI Office of Technology Transfer and Development 
August 27, 2018 will be considered.

ADDRESSES: Requests for copies of the patent applications, inquiries, 
and comments relating to the contemplated exclusive patent license 
should be directed to: Michael Shmilovich, Esq., Senior Licensing and 
Patent Manager, 31 Center Drive, Room 4A29, MSC2479, Bethesda, MD 
20892-2479, phone number 301-435-5019, or [email protected].

SUPPLEMENTARY INFORMATION: The following and all continuing U.S. and 
foreign patents/patent applications thereof are the intellectual 
properties to be licensed under the prospective agreement to Sinotau 
Pharmaceutical Group: U.S. Provisional Patent Application 62/633,648, 
``Chemical Conjugates Of Evans Blue Derivatives And Their Use As 
Radiotherapy And Imaging Agents For Targeting Prostate Cancer,'' filed 
February 22, 2018 (HHS Ref. No. E-054-2018-0). The patent rights in 
this invention have been assigned to the Government of the United 
States of America. The perspective license would be granted worldwide 
and in a field of use not broader than radiotherapeutics for metastatic 
castration-resistant prostate cancer.
    The invention covered by the patents and patent applications 
pertaining to HHS Ref. No. E-054-2018-0 pertain to a therapeutic agent 
that includes a chemically conjugated residue derived from (((R-)-1-
carboxy-2-mercaptoethyl)carbamoyl)-L-glutamic acid that is further 
bound to an Evans blue analog (EB). The EB analog reversibly binds to 
circulating serum albumin to provide a radiopharmaceutical that retains 
affinity and specificity to prostate specific membrane antigen (PSMA; 
in this case PSMA-617). PSMA is a surface molecule shown to be 
specifically expressed by prostate tumor cells. PSMA expression levels 
correlate with disease stage and with hormone refractory cancers. 
Although most PSMA expression appears to be restricted to the prostate 
cancer, low levels of expression can also be detected in the brain, 
kidneys, salivary glands, and small intestine. The antigen is also 
shown to be expressed by neovascular tumor vessels of multiple other 
cancers. Inclusion of the Evans blue analog promotes high 
internalization and retention rates of the conjugated target ligand, 
and therefore, higher accumulation in PSMA positive tumors. Labeling 
EB-PSMA-617 derivatives with the therapeutic beta emitters, e.g., 
\90\Y, \86\Y, and \177\Lu gives rise to improved tumor response and 
survival rates.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive patent license will be royalty 
bearing and may be granted unless within fifteen (15) days from the 
date of this published notice, the NHLBI receives written evidence and 
argument that establishes that the grant of the license would not be 
consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.
    Complete applications for a license in the prospective field of use 
that are timely filed in response to this notice will be treated as 
objections to the grant of the contemplated exclusive patent license.
    Comments and objections submitted to this notice will not be made 
available for public inspection and, to the extent permitted by law, 
will not be released under the Freedom of Information Act, 5 U.S.C. 
552.

    Dated: July 19, 2018.
Michael A. Shmilovich,
Senior Licensing and Patenting Manager, National Heart, Lung, and Blood 
Institute, Office of Technology Transfer and Development.
[FR Doc. 2018-16066 Filed 7-26-18; 8:45 am]
 BILLING CODE 4140-01-P